BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2DX

    MDR report key: 15349512 · Received September 2, 2022

    Report

    Report Number
    3015489752-2022-00002
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 31, 2022
    Manufacturer
    C2DX, INC.
    Product Code
    ILO
    PMA / PMN Number
    K073675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER WAS NOT ABLE TO OBTAIN THE DEVICE OR SPEAK TO OTHER FACILITY REPRESENTATIVES AT TABITHA INC. FACILITY CONFIRMED THAT THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED DURING USE OF THE DEVICE.

    Description of Event or Problem · 0

    (B)(6) CALLED AND SPOKE TO A C2DX REPRESENTATIVE ABOUT THE MAINTENANCE OF THE T/PUMP DEVICE. DURING THE CONVERSATION WITH THE C2DX REP, (B)(6) MENTIONED THAT "THESE BURN PATIENTS ALL THE TIME." (B)(6) WAS NOT WILLING TO GIVE C2DX MORE DETAIL AT THE TIME OF THE COMPLAINT. DURING FOLLOW UP INVESTIGATION, C2DX DISCOVERED THAT THERE WAS A BURN INCIDENT EARLIER THIS YEAR WHEN A PATIENT WAS LEFT ON THEIR BACK FOR A LONG PERIOD OF TIME WITHOUT HAVING THEIR SKIN CHECKED OR MONITORED. AFTER MULTIPLE ATTEMPTS TO CONNECT WITH TABITHA INC., ADDITIONAL DETAILS ABOUT THE INCIDENT WERE NOT PROVIDED TO C2DX, AND TABITHA INC. DID NOT REPORT THIS EVENT TO C2DX AT THE TIME IT OCCURRED. (B)(6) CONFIRMED THAT THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED AND THAT IS THE PATIENT SUFFERED A BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314861 C2DX T/PUMP PROFESSIONAL ILO C2DX, INC. NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention